Maintaining healthy levels of muscle mass and body fat can play an important role in sustaining overall good health, with benefits such as increased basal metabolic rate, better disposal of dietary fats, easier maintenance of lower body fat levels, increased immune system health, and an increase in one's overall vitality and sense of well-being. A number of conditions exist which make it difficult to maintain a normal healthy level of lean muscle mass, including HIV (human immunodeficiency virus), andropause or hypogonadism (subnormal androgen levels), obesity, infection, trauma, bums, and spinal cord injury. Some individuals also fail to gain or to maintain normal lean body mass and body fat without definite pathophysiologic reasons. Many treatments promote the buildup of muscle tissue. Fewer treatments, however, offer the ability to improve and increase lean muscle mass (i.e. insure that skeletal muscle tissue gain is not accompanied by body fat gain, or is even accompanied by a lowering of body fat levels).
Skeletal muscle mass is increased or maintained in the body through a number of distinct mechanisms. Such mechanisms play a role in the regulation of either skeletal muscle protein synthesis or breakdown. Collectively, they control the total amount of accrued protein present in the muscle cell. The actions of androgens are tied to the regulation of skeletal muscle mass. It is well documented that raising the level of androgenic hormones in the body can increase skeletal muscle mass. A number of methods have similarly been developed to increase the level of androgenic hormones in the body, which ultimately can be used to offer the benefits of increased skeletal muscle mass in humans. The use of androgenic hormones in general, however, is thought to be relevant to the development of undesirable side effects such as gynecomastia, water retention (edema), fat buildup, unfavorable alterations in cholesterol levels (increased heart disease risk), and increased blood pressure. If an individual seeking to increase skeletal muscle mass is not in need of androgen replacement, then the methods regarding the use of androgens may be less than ideal.
U.S. Pat. No. 6,841,573 (“the '573 patent”) relates to a method of using arachidonic acid for increasing PGF2-alpha, protein synthesis rates, and skeletal muscle mass. The '573 patent provides a solution for an individual in need of increasing skeletal muscle mass, because PGF2-alpha is non-steroidal, and can increase protein synthesis and muscle mass without the potential undesirable side effects associated with altering sex steroid levels with androgen hormones. Due to the high cost of manufacture and supplementation, however, arachidonic acid may not be an ideal solution for everyone. Therefore, it is an object of this invention to provide alternative compositions and methods for improving lean muscle mass, or the ration of lean to fat mass, in humans.